Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia (UNITE-VT)

Using Non-Invasive Mapping To Eliminate Structural Heart Disease Ventricular Tachycardia: a UK Randomised Controlled Trial

Ventricular tachycardia (VT) is an abnormal and dangerous heart rhythm affecting the lower chambers of the heart (the ventricles). Patients with structural heart disease caused by previous heart attacks are at an increased risk of developing VT. Current guidelines recommend that patients who develop this abnormal heart rhythm are considered for invasive catheter ablation (ICA). This is an invasive procedure where specialised catheters and a 3D electro anatomical mapping (EAM) system are used to identify the region of the heart responsible for the VT, which is then treated by tissue heating or freezing (ablation). Although significant improvements have been made in both mapping and ablation technologies, these procedures remain technically challenging and time consuming.

View into ventricular onset (VIVO, Catheter Precision) is a non-invasive, mapping system already being used within the NHS. It uses images from previous heart scans, a picture of the patient's chest (taken at the start of the procedure) and a 12-lead electrocardiogram (ECG) tracing, to locate where the VT is coming from. The VIVO map can therefore highlight the likely region of interest for ICA prior to invasive EAM.

This study will be a prospective, multi-centre, two-arm, non-blinded, randomised controlled trial (RCT). Patients will be evenly randomised (50:50) into a standard VT ablation group and a VIVO guided ablation group. In the VIVO guided ablation group, invasive EAM will be restricted to the region of interest identified using the VIVO map, rather than whole chamber mapping required for standard ablation. The primary objective will be to determine if the VIVO non-invasive mapping system reduces procedure duration and therefore improves workflow efficiency. Secondary objectives will assess the procedural success, safety and patient perceived health benefits of a VIVO guided ablation versus standard ablation.

Study Overview

• Status: Recruiting
• Conditions: Ventricular Tachycardia (VT); Catheter Ablation
• Intervention / Treatment: Device: VIVO-assisted mapping

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Brighton, United Kingdom, BN2 1ES
    • Not yet recruiting
    • Royal Sussex County Hospital
    • Contact: John Silberbauer, Dr.; Phone Number: 01273 664943; Email: john.silberbauer@nhs.net
  • Coventry, United Kingdom, CV2 2DX
    • Recruiting
    • University Hospitals Coventry and Warwickshire
    • Contact: Tarv Dhanjal, Dr.; Phone Number: 02476 966400; Email: Tarv.Dhanjal@uhcw.nhs.uk
    • Contact: Jaffar Al-Sheikhli, Dr.; Phone Number: 024 7696 2415; Email: Jaffar.Al-Sheikhli@uhcw.nhs.uk
  • Middlesbrough, United Kingdom, TS4 3B
    • Recruiting
    • The James Cook University Hospital
    • Contact: Matthew Bates, Dr.; Phone Number: 58229 01642 858229; Email: matthew.bates1@nhs.net
    • Contact: Simon James, Dr.; Email: simon.james1@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ≥18 years old

• Patient with the following:

  • Evidence of post-myocardial infarction* structural heart disease.
  • Cardiac CT and/or cardiac MRI scan performed within 6 months.
  • ICD/CRTD implantation.
  • Device therapy for VT: at least 1 appropriate ICD shock or 3 ATP episodes within a 6-month period.
• Suitable candidate for VT ablation as per NHS standard of care.
• Patient agrees to comply with study procedures and be available for routine follow up visits for at least 6 months after enrolment.

Exclusion Criteria:

• Lacks capacity to provide informed consent.
• Presence of intramural thrombus, tumour or abnormality that precludes vascular access, catheter introduction or manipulations.
• Coagulopathy, bleeding diathesis or suspected pro-coagulant state.
• Sepsis, active systemic infection or fever (>100.5 F/38 C) within a week prior to the ablation procedure.
• Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the patient or deem the patient inappropriate to participate in the study.
• Known allergies or intolerance to AADs to be used to treat PVCs.
• Known allergy for contrast.
• Female patients who are pregnant or breast feeding.
• Enrolment in a concurrent interventional clinical study that in the judgement of the investigator would increase risk to the patient or deem them inappropriate to participate in this study.
• Other conditions that may prevent patients from adhering to the study protocol, in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VIVO-assisted VT ablation	Device: VIVO-assisted mapping; VIVO (or View Into Ventricular Onset) is a non-invasive cardiac mapping technology which uses images from patients' previous heart scans, a picture of their chest (taken at the start of the procedure) and a tracing of their VT, to locate where the ventricular tachycardia is coming from.
No Intervention: Standard VT Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total procedural time (minutes)	the time from first incision (needle to skin) to the removal of the venous/arterial sheaths	day of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time in VT (minutes)		during VT ablation procedure
Mapping time (minutes)		during VT ablation procedure
Ablation time (minutes).		During VT ablation procedure
Total number of ablation applications		During ablation procedure
Total number of shocks delivered		during the VT ablation procedure
Number of Participants with VT non-inducibility determined by Programmed Ventricular Stimulation (PVS)		during VT ablation procedure
Number of Participants with substrate modification confirmed by remap		during the VT ablation procedure
Total number of ICD/CRTD determined appropriate shock events	Total number of ICD/CRTD shock events per patient will be documented on database	day of procedure to 6 months post-procedure
Total number of ICD/CRTD determined anti-tachycardia pacing (ATP) events	Total number of ICD/CRTD ATP events per patient will be documented on database	day of procedure to 6 months post-procedure
Total number of VT episodes as determined from ICD/CRTD		day of procedure to 6 months post-procedure
Recognised VT ablation procedural complications		day of the procedure to 30 days after the VT ablation procedure
Total number of hospitalisations	Total number of hospitalisation events per patient will be documented on database	day of the procedure to 30 days after the VT ablation procedure
Mortality		day of the procedure to 30 days after the VT ablation procedure
Perceived health benefit of treatment	EQ-5D-5L	at baseline and 6 months

Collaborators and Investigators

• Sponsor: University of Warwick
• Collaborators: University Hospitals Coventry and Warwickshire NHS Trust

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): February 29, 2028

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: August 6, 2026
• First Posted (Actual): August 12, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 6, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: ablation; Ventricular tachycardia; clinical outcomes; VT; non-invasive mapping; procedural VT duration; procedural efficiency
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular
• Other Study ID Numbers: TD660525; SOC.12/24-25 (Other Identifier: University of Warwick)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised participant data will be made available by the Sponsor following official request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No